Actively Recruiting
A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis
Led by Prime Gene Therapeutics Co., Ltd. · Updated on 2025-05-20
472
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Multicenter, Randomized, Double-blind, Placebo-controlled seamless and adaptive-designed phase IIb/III study to Assess the Efficacy and Safety of topical use of PG-011 Gel in adolescents and Adults With Atopic Dermatitis. It consists of phase IIb and phase III parts, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time. The goal of this phase III clinical trial is to learn if PG-011gel works to treat mild to moderate Atopic Dermatitis in adolescents and adults by topical use. It will also learn about the safety of PG-011gel. Investigators will compare PG-011gel to a placebo (a look-alike substance that contains no drug) to see if PG-011gel works to treat mild to moderate Atopic Dermatitis. Participants will: * Use PG-011gel or a placebo twice daily for initial 8 weeks, and followed by using PG-011 gel for all of the participants till 52-week. * Visit the clinic at weeks 1, 2, 4 and 8 for checkups and tests, and followed by visiting the clinic every 4 weeks till 52-week. * Keep a diary of their symptoms.
CONDITIONS
Official Title
A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 75 years old, male or female.
- Diagnosed with atopic dermatitis according to Williams diagnostic criteria.
- Atopic dermatitis duration of at least 6 months for adolescents and at least 1 year for adults.
- Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at screening and day 1.
- Atopic dermatitis involvement of 10% to 20% body surface area excluding scalp.
- Willing to avoid pregnancy or fathering children as outlined in the protocol.
You will not qualify if you...
- Unstable course of atopic dermatitis (improving or worsening rapidly).
- Immunocompromised conditions such as lymphoma, AIDS, or Wiskott-Aldrich syndrome.
- Other skin disorders that may interfere with evaluation or safety, like generalized erythroderma or psoriasis.
- Recent treatment with systemic antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before randomization.
- Active acute or chronic skin infections including herpes simplex, herpes zoster, or chickenpox.
- HIV infection, active hepatitis C or B infections, or positive Treponema pallidum antibody with active disease.
- Significant or uncontrolled cardiovascular disease.
- Serious diseases affecting major organ systems that may influence safety or efficacy assessments.
- Mental illnesses such as anxiety or depression affecting compliance.
- History of malignant tumors before randomization.
- Severe uncontrolled diseases affecting safety or study compliance.
- Lactating or pregnant females at screening.
- Any condition judged by investigators to affect safety or study evaluation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
Research Team
X
Xinghua Gao, Professor
CONTACT
L
Li Zhang, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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